| Inclusion Criteria: | 1) Patient must have an ECOG/Zubrod performance status of less than or equal to 2.
2) Patient must have T2-T4c, any N, M0 breast cancer, by clinical staging. NOTE: Primary tumor must be palpable and measure great than 2 cm by tape, ruler or caliper measurements in at least one dimension.
3) Patient must be postmenopausal, verified by a) bilateral surgical oophorectomy; or b) No spontaneous menses greater than or equal to 1 year; c) No menses for less than 1 year with FSH and estradiol levels in postmenopausal range, according to institutional standards
4) Patient, as documented by the treating physician, is clinically staged as one of the following: a) T4 a-c for whom modified radical mastectomy with negative margins is the goal; b) T2 or T3 for whom conversion from needing mastectomy to breast conservation is the goal; c) T2 for whom lumpectomy at first attempt is the goal
5) Patient has an ER+ tumor with an Allred score of 6, 7 or 8. Note: Patients with greater than 66.6% (two-thirds) of cells staining positive have a minimum Allred score of 6 and are eligible.
6) Patient must have mammogram and ultrasound within 42 days prior to registration.
7) If patient is a cancer survivor, all of the following criteria must be met: a) Patient has undergone potentially curative therapy for all prior malignancies; b) No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, contralateral DCIS treated with mastectomy or lumpectomy and radiation, but without tamoxifen treatment,or non-melanoma skin cancer with no evidence of recurrence);
8) Continued from Inclusion # 7: and, c) Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies
9) This inclusion criteria is only in the M. D. Anderson Abstract and is not in the protocol. It applies to M. D. Anderson patients only: Any patient with T2-T4 tumors, excluding T4d, classified as requiring mastectomy by surgeon at baseline and unlikely to be breast conservation surgery (bcs) candidates after completing protocol, can be considered for enrollment.
10) This inclusion criteria is only in the M. D. Anderson Abstract and is not in the protocol. It applies to M. D. Anderson patients only: Any patient desiring mastectomy prior to enrolling on protocol and desiring mastectomy at completion of protocol can be considered for enrollment. |